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Petra Pharma announces licensing agreement with Takeda Pharmaceutical Company

On March 20, 2019 Petra Pharma Corporation ("Petra"), a leader in phosphoinositide (PI) signaling pathway inhibition, reported it has secured a global license from Takeda Pharmaceutical Company Limited ("Takeda") to develop, manufacture and commercialize serabelisib and two additional PI3Kα-specific inhibitors (Press release, Petra Pharma, MAR 20, 2019, View Source [SID1234554009]). The agreement grants Petra a license for all human therapeutic uses, except for a subset of undisclosed rare-disease indications, which Takeda had previously out-licensed.

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Petra plans to initiate a Phase 1b/2 study with serabelisib in late 2019 to advance pioneering research and insights in PI signaling pathways with a focus on PIK3CA-mutated solid tumors. The PI3K signaling pathway is a frequently mutated pathway in human cancer.

"Today marks a transformational moment for Petra and a new era in the therapeutic use of PI3K inhibitors. We are pioneering new approaches that have the potential to increase tumor responses with PI3K inhibitors and minimize side effects, with profound clinical implications for patients diagnosed with a PIK3CA-mutated tumor," said President and CEO, Brian O’Callaghan.

Petra’s leading-edge research builds on the recent work of Scientific Co-Founder, Lewis Cantley, Ph.D. (Weill Cornell Medical Center) and his collaborators, whose paper in the August 2018 issue of Nature* identified strategies to disrupt the glucose/insulin feedback loop with the potential to dramatically improve the anti-tumor response.

"Current treatment modalities have been challenging due to an on-target effect of PI3Kα inhibitors causing hyperglycemia and consequent elevation of serum insulin, which can re-activate PI3K in tumors, allowing them to survive," said Dr. Cantley. "The approach Petra is taking disrupts the glucose/insulin feedback loop, which in preclinical models significantly increases anti-tumor efficacy."

This is the first licensing agreement between Petra and Takeda. Financial terms of the agreement were not disclosed.

* Hopkins BD, Pauli C, Du X, et al. Suppression of insulin feedback enhances the efficacy of PI3K inhibitors. Nature. 2018;560(7719):499-503.

PDCline Pharma enters into a licensing agreement with leading Korean pharmaceutical company LG Chem to develop PDClung cancer vaccine in Asia

On March 20, 2019 PDC*line Pharma, a biotech company developing a new class of potent and scalable antigen presenting cell, based on a proprietary cell line of Plasmacytoid Dendritic cells (PDC*line), reported that it has signed an exclusive licensing and option agreement with LG Chem Life Sciences Company, the life sciences division of LG Chem Ltd (Press release, PDC Line Pharma, MAR 20, 2019, View Source [SID1234553824]). This agreement, which includes a development and commercialization collaboration agreement, opens new markets to PDC*line Pharma and expands the global footprint of its PDC*line-based cancer vaccine.

Under the terms of the agreements, PDC*line Pharma will co-operate with LG Chem, who will have the full rights in South Korea and an exclusive option for other Asian countries, to develop and commercialize the company’s drug candidate, PDC*lung, in lung cancer. PDC*lung is constituted of a PDC*line loaded with HLA-A2 restricted peptides derived from six shared tumor antigens.

PDC*line Pharma is eligible for upfront and near-term milestone payments, plus longerterm clinical development and regulatory milestones totaling up to €108M ($123M). The company will also receive royalties based on net sales of the licensed product in LG Chem’s Asian markets.

Under the terms of the agreement, PDC*line Pharma will continue developing its PDC*lung candidate in the EU, US and global markets outside of Asia, and LG Chem will be responsible for future development and commercialization in its territories.

Eric Halioua, president & CEO of PDC*line Pharma, said: "We are very pleased to cooperate with LG Chem and to start the development of our PDC*lung cancer vaccine in Asia. This licensing agreement is a great opportunity for PDC*line Pharma to expand the scope of its immuno-oncology clinical programs and bring our technology to numerous patients around the world. Furthermore, the agreement with LG-Chem Life Sciences Company, a leading pharmaceutical company in Korea, is a major endorsement for our unique PDC*line approach and its potential."

Dr. Jeewoong Son, president of LG-Chem Life Sciences, said: " We are delighted to start this strategic collaboration with PDC*line Pharma, a great partnership to further expand LG Chem’s cell-based cancer immunotherapy portfolio. PDC*line Pharma’s technology is backed by cutting-edge science and we believe we can extend its reach by bringing this novel therapy to a greater number of cancer patients."

Xynomic Pharmaceuticals, Inc. Will Present at ASCO 2019 Annual Meeting, Will Sponsor an EU Investigator Meeting for Potentially Pivotal Kidney Cancer Trial, and Appoints Interim Chief Accounting Officer

On March 20, 2019 Xynomic Pharmaceuticals, Inc. ("Xynomic"), a clinical stage US-China oncology drug development company, and Bison Capital Acquisition Corporation (Nasdaq: BCAC), jointly reported that Xynomic and its collaborators will present at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ("ASCO") 2019 Annual Meeting to be held in Chicago from May 31, 2019 – June 4, 2019 (Press release, Xynomic Pharmaceuticals, MAR 20, 2019, View Source [SID1234534943]). The presentation will show Phase 1 data of XP-105 (also known as BI 860585), Xynomic’s Phase 2 ready, ATP-competitive, third generation mTORC1/2 Inhibitor, used alone or in combination with exemestane or paclitaxel in patients with advanced solid tumors. XP-105 is a potent dual inhibitor designed to overcome mTORC1 inhibition resistance. An oral presentation titled "A Dose Escalation Pharmacokinetic (PK) and Pharmacodynamic (PD) Study of mTORC1/2 Inhibitor XP-105 (BI 860585) as Monotherapy and in Combination with Exemestane or Paclitaxel in Patients (pts) with Advanced Solid Tumors" will be presented by Dr. Filippo G. De Braud, a lead investigator at Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy. This Phase 1 trial enrolled a total of 90 patients; 41 were in Arm A where XP-105 was used as a monotherapy (the "monotherapy arm"), 25 were in Arm B where XP-105 was used in combination with exemestane (the "exemestane combination arm"), and 24 were in Arm C where XP-105 was used in combination with paclitaxel (the "paclitaxel combination arm"). Combination regimens showed higher activity as compared to monotherapy. In the monotherapy arm, stable disease ("SD") was reported in 8 pts (20%), with a median duration of 11 months. In the exemestane combination arm, 4 (16%) partial responses ("PR") were reported. In the paclitaxel combination arm, 1 complete response ("CR") and 4 PRs were reported (OR rate 21%). Disease control rate (CR/PR/SD) was 20%, 28%, and 58% in the monotherapy, XP-105/exemestane, and XP-105/paclitaxel arms, respectively. In the XP-105/paclitaxel combination the most frequent drug-related adverse events ("AEs") were diarrhea and fatigue (58.3% each), hyperglycaemia (54.2%), and anaemia (50%). Grade ≥3 AEs were hyperglycaemia, fatigue, diarrhea, anaemia, and leukopenia.

In addition, Xynomic will sponsor an investigator meeting on Friday, March 22, 2019 in Athens, Greece. The investigator meeting will bring together European Union ("EU") physicians, care providers and clinical research coordinators. The participants are from current and prospective clinical trial sites in the potentially pivotal Phase 3 clinical trial of testing Xynomic’s abexinostat, in combination with pazopanib, against renal cell carcinoma. The participants will be presented with trial design, protocol, and study management as a part of the preparation of the trial start and patient recruitment.

Furthermore, Xynomic’s board of directors has appointed Ms. Jinwei Coco Kou as the Interim Chief Accounting Officer. Ms. Kou is responsible for overseeing all accounting functions such as ledger accounts, financial statements, and cost control systems. Before joining Xynomic, Ms. Kou had extensive experience in internal controls, multinational operations and corporate finance of high-tech companies. From 2017-2018, Ms. Kou was the Chief Financial Officer at Salion Food Condiment Company Limited (a company approved for listing by the Hong Kong Stock Exchange). From 2008-2016, she was a Managing Director at Marcum Bernstein & Pinchuk LLP, one of the largest independent public accounting and advisory services firms in the United States, with multinational offices. From 2005-2008, Ms. Kou worked for Deloitte Touche Tohmatsu. Ms. Kou is a CPA in both the United States and China. Ms. Kou holds a Bachelor degree in Economics majoring in Finance, and a Master’s degree in Economics majoring in Risk Management and Insurance, both from Peking University. Ms. Kou holds an Executive MBA degree jointly granted by Columbia Business School, London Business School and Hong Kong University Business School.

Dynavax to Present on Inhaled TLR9 Agonist DV281 at the AACR Annual Meeting 2019

On March 20, 2019 Dynavax Technologies Corporation (NASDAQ: DVAX), a fully-integrated biopharmaceutical company focused on discovering and developing novel vaccines and immuno-oncology therapeutics, reported it will present safety and biomarker data for DV281, its inhaled TLR9 agonist, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2019, being held March 29 – April 3, in Atlanta, Georgia (Press release, Dynavax Technologies, MAR 20, 2019, View Source [SID1234534546]).

Abstract Number and Title: #8304, "Phase Ib/II, open label, multicenter study of inhaled DV281, a Toll-like receptor 9 agonist, in combination with nivolumab in patients with advanced or metastatic non-small cell lung cancer (NSCLC)"

Poster Session Title: Phase I-III Trials in Progress: Part 3

Session Date and Time:Tuesday, April 2, 2019, 1 – 5 p.m. ET

Session Location: Georgia World Congress Center, Exhibit Hall B, Poster Section 17, Poster Board Number: #18

Permanent Abstract Number: CT224

About DV281
DV281 is Dynavax’s proprietary investigational TLR9 agonist designed specifically for focused delivery to primary lung tumors and lung metastases. DV281 is similar in biological activity and mechanism of action to Dynavax’s Phase 2 immunotherapy candidate, SD-101, but has been optimized for administration as an inhaled therapy. Both SD-101 and DV281 activate plasmacytoid dendritic cells which then stimulate T cells specific for antigens released from dying tumor cells. TLR9 agonists such as DV281 and SD-101 have been shown to stimulate potent Type 1 interferon induction along with maturation of dendritic cells to effective antigen-presenting cells; both activities are important for the induction of effective anti-tumor immunity.

Organics Announces Proposed Underwritten Public Offering

On March 20, 2019 Oragenics, Inc. (NYSE American: OGEN), a leader in the development of new antibiotics against infectious diseases and effective treatments for oral mucositis, reported that it has commenced a proposed underwritten public offering of common stock of the Company, together with warrants to purchase shares of common stock (Press release, Oragenics, MAR 20, 2019, View Source [SID1234534524]). In addition, the Company expects to grant the underwriter of the offering, a 30-day option to purchase additional shares of common stock and/or warrants at the public offering price, less underwriting discounts and commissions. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

H.C. Wainwright & Co. is acting as sole book-running manager for the offering.

The Company intends to use the net proceeds of the offering to fund its AG013 research, clinical trials, pre-clinical development of the lantibiotics program, and for working capital and general corporate purposes.

The securities described above are being offered pursuant to a shelf registration statement (File No. 333-213321), which was declared effective by the United States Securities and Exchange Commission ("SEC") on September 7, 2016. A preliminary prospectus supplement relating to the offering will be filed with the SEC. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to this offering may be obtained, when available, at the SEC’s website at www.sec.gov. Electronic copies of the preliminary prospectus supplement and accompanying prospectus also may be obtained, when available, from H.C. Wainwright & Co., LLC, 430 Park Avenue, 3rd Floor, New York, NY 10022, email: [email protected].

Before you invest, you should read the preliminary prospectus supplement and the accompanying prospectus in the registration statement and other documents Oragenics has filed or will file with the SEC for more complete information about Oragenics and the offering.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the Company’s securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.